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Ma XM, Geng K, Wang P, Jiang Z, Law BY, Xu Y

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Recommended reconstitution by protocol phase This phased approach uses different vial sizes at different stages, matching the vial to the dose rather than forcing one size to work across all phases

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Staff cited inadequate substance characterization, uncertain product quality, insufficient evidence of effectiveness for ulcerative colitis, sparse human safety data, and unresolved risks such as immunogenicity, aggregation, impurities, and long-term exposure